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Alleged medical negligence in Bariatric Surgery: Forum exonerates Chennai Hospital, doctor, dismisses Rs 6 crore compensation case
Chennai: The National Consumer Disputes Redressal Commission (NCDRC) has exonerated a doctor and a Chennai hospital from charges of medical negligence in obesity treatment by Bariatric Surgery of a patient who eventually died.
Presiding Member, Dr S. M Kantikar dismissed the case of medical negligence against Life Line Hospital and the doctor noting that the deceased patient's father, who prayed compensation of Rs 6 crore as punitive damages, failed to prove his case.
In a nutshell, the allegations of the complainant were that the hospital and the doctor failed to categorise the patient's obesity, eligibility for surgery, negligently prescribed the dietary supplement 'Optifast', the hospital hygiene was lost due to commercial venture by allowing film shooting in the same floor where operation theatres were located and the dusty construction activity. Some other allegations like medical record was fabricated, no pre-operative assessment and the doctor was not qualified and inexperienced.
The case revolves around a 20-year old patient who met the doctor in a gathering who assured his obesity treatment by Bariatric Surgery without any complications at Lifeline Hospital, Chennai and he would lose about 50 Kg weight in 3-6 months and thereafter another 40 Kgs. The package of treatment was given Rs.3.25/- lakh. It was informed that the surgery was to be done in two steps i.e. 'Sleeve Gastrectomy' and then 'Duodenal Switch'. The doctor explained about the side effects and risks and gave the warning that the patient had to eat in smaller quantity of food at more frequent intervals.
Accordingly, on 24.03.2006 the doctor examined the patient and confirmed his Bio-Mass Index (BMI) as 64/65 and categorised the patient under super obese category. The doctor started on diet supplements called Optifast. The patient was admitted to Lifeline Hospital, Chennai on 04.04.2006 and the doctor performed the laparoscopic 'Sleeve Gastrectomy' on 05.04.2006.
After the surgery, the doctor told the patient's father that the second procedure 'Duodenal Switch' was not necessary. On 06.04.2006 the patient was shifted to ward. On 08.04.2006, in the morning, patient complained severe abdominal pain. It was alleged that the doctor after examination told that there was a fluid collection in the abdomen and advised in the evening to perform an emergency short procedure (45 minutes) to remove the collection; but later on it was learnt that he had performed a regular surgery (exploratory laparotomy) by opening patient's abdomen.
After 3- 4 days, the doctor informed the patient's father about the leak in the abdomen, therefore the patient was put on ventilator for better recovery. On 11.04.2006, the doctor informed him that patient developed septic shock and started injection Xigris costing about Rs. 2.5 lakh per injection.
Five days later, further 'Cansidas' a medicine for the fungal infection was started. It was alleged that due to prolonged ventilation, the doctor performed tracheostomy on 21.04.2006 and on the next day the patient was shifted to isolation ICU. On 25.04.2006, the doctor informed the patient's father and relatives that a leak was found and that the patient was having a 'Gastric Fistula'. Thus, moping was needed for fast recovery. After 2 hours of the procedure, the doctor informed the patient's father that a third surgery for stomach removal might be necessary. Therefore, the father alleged that the previous two surgeries were failure. The doctor referred the patient to Dr. Surendran at Apollo Hospital on 26.04.2006 only after paying total amount paid was Rs.27 lakhs while the package promised was for Rs. 3.25 lakhs. It was alleged that, the patient's father came to know about the life-threatening infection from the doctors only on 26.04.2006, after admission to Apollo Hospital.
Being aggrieved, the father of the deceased filed the Consumer Complaint through Consumer Protection Council, Tamil Nadu against both the doctor and the hospital and prayed compensation of Rs. 5 Crores plus Rs. 1 crore as punitive damages and Rs.50,000 to each Complainant towards cost of litigation.
The authorized representative S. Pushpavanam, the Secretary of Consumer Protection Council, Tamil Nadu argued on behalf of Complainants. He submitted that, this case pertains to wrong classification, negligence and defective Bariatric surgery on a young boy. He argued;
"The doctor misled the patient who believed that the operation would get rid him of obesity and avoid future risks. The patient was wrongly classified under Super obese category; but on the basis of BMI 64/65, weight 195 kg he ought to have been classified as Super Super obese. The mode of treatment changes as per the category of obesity. As per medical literature Bariatric surgery should be done when other nonsurgical methods failed and if life-threatening situation. In the instant case, the patient was normal before surgery, without any threat to his life."
Meanwhile, the counsel for the hospital and the doctor submitted that, previously the patient took non-surgical treatment at R.K. Nature's Centre in Coimbatore, it is evident from the evidence of patient's mother before the trial court. He argued that to facilitate to take expert opinion, the hospital issued original medical records on 16.05.2006 to R. K. Ramanathan on written request.
He further argued, "Methylene Blue test to detect leak after surgery was conducted. In present days it is not mandatory and hardly practiced by the Bariatric Surgeon. The Complainant manipulated / tempered the documents D-7 & P-23 by editing original contents electronically. It was detected by the forensic expert. He further argued that Dr. Surendran of Apollo Hospital was an interested party in the instant case and was not a Bariatric surgeon said to be an expert. The external drain put on 11.04.2006 was present still the time of discharge. The doctor in question is a well-qualified and experienced. He performed more than 100 surgeries before the instant case. He had adequate experience and expertise. The Tamil Nadu Medical Council (TNMC) and the committee constituted by the Director of Medical Education (DME) of three experts did not hold the doctor for medical negligence."
After examining the facts of the case, the Commission opined that it is pertinent to note that, the trial court after expediently looking into the method of selection of "sleeve gastrectomy" concluded that it was the simple and less complex procedure rather than other procedures and therefore held that, there was no wrong committed in selection of this procedure in bariatric surgery. It also noted that "intra-operative methylene blue test was done, but no leak was detected".
In the apex consumer court's view, as per literatures, methylene blue test after surgery is not mandatory and now hardly being practiced by Bariatric surgeons. It observed,
"The allegation of not issuing medical record is not acceptable the Medical Superintendent issued the original record and obtained signature of Mr. Ramnathan. After shifting to Apollo Hospital, the necessary emergency surgery was not performed. The cause of death given as by Apollo Hospital was Post-operative Gastric fistula / sepsis, therefore postmortem was not done."
From the credentials on record, NCDRC found that the doctor is a well-qualified, competent and experienced laparoscopic surgeon undergone special training on Bariatric surgery. In its observation, the Commission added that some opinions from best of the bariatric surgeons in India ruled out negligence on part of the doctor during surgery. Further, the TNMC and the committee of DME of 3 experts concluded that there was no negligence.
It went on to noted, "Optifast is not a medicine, but a very low calorie dietary supplement. It has no significant role for weight reduction in super obese patients and not mandatory to take for 6-9 weeks in super obese patients with BMI> 60."
"It should be borne in mind that the treatment package includes methylene blue test. However, in case for the repeat methylene blue test done post operatively, it was to be charged and reflected in the list of consumables. Therefore, the allegation of complainant about Methylene blue test was not done, is not acceptable to us, " the Commission mentioned in its observation.
Perusing the expert opinion from AIIMS, the Commission noted, "On collective reading of the expert opinions (supra), in our view, the procedures and treatment followed by the doctor cannot be faulted. The doctor acted with the accepted reasonable standard of practice. Any post-operative complication/ mishap or happening straightway cannot constitute negligence."
It further relied on the recent judgment of Hon'ble Supreme Court in the case of Dr. (Mrs.) Chanda Rani Akhouri & Ors. Vs Dr. MA Methusethupathi & Ors.[9] has laid down in no uncertain terms that merely because doctors could not save the patient, he/she cannot be held liable for medical negligence.
Considering the entirety and the expert opinions, the medical record and the literature on the subject it held;
"To sum up, in our considered view admittedly the patient was super obese category. The pre-operative routine investigations, TMT and ECHO were found within normal limit. As per standard protocol, on 05.04.4006 the doctor performed Sleeve Gastrectomy, the 1st stage of bariatric surgery. It was uneventful. After 4 days patient had symptoms of abdominal pain and on USG examination fluid collection seen, therefore on 08.04.20062nd surgery for closure of gastric leak was performed with interrupted 2.0 vicryl stitches and omental onlay patch. The medical record revealed us the patient was continuously monitored with relevant investigations like culture and sensitivity, electrolytes, ABG etc. The patient was under intensive care of specialists throughout for the treatment of sepsis. On 25.04.2006 patient developed features of gastric fistula, therefore emergency surgery was suggested, but it was refused by the patient's relatives. The 3rd emergency surgery was necessary which might have saved the patient. Moreover, we ignore the vague and unrelated submissions made by the AR for Complainant about the treatment of VIPs/ministers like Mr. Nitin Gadkari, late Mr. Arun Jaitley and Vice President Mr. Venkaih Naidu, who successfully took such treatment without any complications. It is also evident that Dr. Shrihari Dhorepatil at Pune who is considered as the father of Bariatric surgery; opined that there was no negligence from the doctor. We further note the the hospital and the doctor took informed consent at every stage of treatment like laparotomy for gastric peroration closure, tracheostomy and other procedures. Also high risk handwritten informed consent is on record. We further note that on 26.04.2006 at the time of DAMA discharge the patient's relative in his handwriting clearly stated that on their own risk transporting the patient and for any untoward incident the doctor and the hospital or their staff are not liable. It was signed by the father of the Patient."
Subsequently, it dismissed the case noting;
"The allegations need to be proved with cogent evidence. The complainant conclusively failed to prove medical negligence of the opposite parties. The instant complaint is dismissed."
To view the original order click on the link below:
Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751